Label: BERKLEY JENSEN ANTIBACTERIAL HAND- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68391-150-64 - Packager: BJWC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 10, 2014
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INACTIVE INGREDIENTS
WATER (AQUA), COCAMIDOPROPYL BETAINE, GLYCERIN, DECYL GLUCOSIDE, HYDROXYETHYLCELLULOSE, ALOE BARBADENSIS LEAF JUICE, FRAGRANCE (PARFUM), POLOXAMER 124, POLYQUATERNIUM-7, TETRASODIUM EDTA, CITRIC ACID, SODIUM CITRATE, CAMELLIA SINENSIS LEAF EXTRACT, SACCHAROMYCES FERMENT, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, NIACINAMIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200)
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INGREDIENTS AND APPEARANCE
BERKLEY JENSEN ANTIBACTERIAL HAND
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) HYPROMELLOSES (UNII: 3NXW29V3WO) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLOXAMER 124 (UNII: 1S66E28KXA) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) EDETATE SODIUM (UNII: MP1J8420LU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE (UNII: 1Q73Q2JULR) GREEN TEA LEAF (UNII: W2ZU1RY8B0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBYL PALMITATE (UNII: QN83US2B0N) NIACINAMIDE (UNII: 25X51I8RD4) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68391-150-64 1890 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/09/2014 Labeler - BJWC (159082692) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(68391-150)